Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

79 results found

Title
Status

 

BO41932 (TAPISTRY) - Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Open

BO41932 (TAPISTRY) - Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

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DiagnosisSolid tumors with eligible genetic changeStudy StatusOpen
PhaseII
AgeChild (Under 18 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationEntrectinib - oral Atezolizumab - IV Ipatasertib - oral Alectinib - oral Trastuzumab - IV GDC-0077 (Inavolisib) - oral Belvarafenib - oral Pralsetinib - oral
Last Posted Update2023-08-03
ClinicalTrials.gov #NCT04589845
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

(from https://forpatients.roche.com/en/trials/cancer/solid-tumors/tumor-agnostic-precision-immuno-oncology-and-somatic-ta-50851.html)

This clinical trial is recruiting people who have advanced solid tumors that cannot be surgically removed. You (or your child) must have had genetic testing on the solid tumors that shows a positive result for one of the genetic changes, also known as biomarkers, being tested in this trial.

The purpose of this clinical trial is to compare the effects, good or bad, of different targeted therapies and immunotherapies in patients with solid tumors that cannot be surgically removed and show specific biomarkers.

To be able to take part in this clinical trial, you (or your child) must have been diagnosed with solid tumors that cannot be surgically removed and show one of the specific biomarkers that are being tested in this study:

  • ROS1 fusion-positive tumors
  • NTRK1/2/3 fusion-positive tumors
  • TMB-high tumors
  • ALK fusion-positive
  • AKT1/2/3 mutant-positive tumors
  • HER2 mutant-positive tumors
  • PIK3CA multiple mutant-positive tumors
  • BRAF class II mutant or fusion-positive tumors
  • BRAF class III mutant-positive tumors
  • RET fusion-positive tumors

Your doctor will be able to give you more information on the type of biomarker your solid tumors show. You must be otherwise in good health to take part. You will not be able to take part if you are pregnant or breastfeeding, or if you have received any recent treatment for your cancer. Some of the groups may have other specific requirements. Your doctor will be able to give you more information on this.

Inclusion Criteria
  • Less than 18 years of age for cohort E and K
  • Age between 12 and 17 years for cohorts E, F and H
  • Diagnosis of advanced cancer that has spread to a different part of the body (metastasized) and can’t be removed by an operation (unresectable)
  • Participants must be up and about at least 50% of their waking hours
  • The cancer must have a specific genetic change in one of the following genes: ROS1, NTRK1/2/3, AKT, PIK3CA, HER2, BRAF, RET, or be TMB-high

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

DAY101-102 - A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

Open

DAY101-102 - A Phase 1b/2, Open Label Study of DAY101 Monotherapy or Combination With Other Therapies for Patients With Recurrent, Progressive, or Refractory Solid Tumors Harboring MAPK Pathway Aberrations

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DiagnosisNon-hematological tumours (solid and brain) with relevant biomarkerStudy StatusOpen
PhaseI/II
Age12 Years and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: DAY101 (Oral tablet) Drug: Pimasertib Hydrochloride (Oral capsule) - Sub-study B only.
Last Posted Update2023-06-27
ClinicalTrials.gov #NCT04985604
International Sponsor
Day One Biopharmaceuticals, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a Phase 1b/2 study of the drug DAY101 in patients ≥12 years of age with solid tumours or brain tumours that have come back or progressed. This study includes 2 sub-studies, patients in sub-study A will receive the DAY-101 drug and patients in sub-study B will receive "DAY-101" and another drug called pimasertib in combination.

Inclusion Criteria
  • Participants must be between 12 to 18 years old
  • Participants must have a solid tumour or brain tumour that has come back (relapsed) or progressed 
  • Participants must have a qualifying gene change in the tumour (MAPK pathway)
  • If enrolled on study, patients and their families must agree to the study requirements by signing an informed consent/assent form

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

BT016C - HIFU - A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)

Open

BT016C - HIFU - A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)

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DiagnosisBrain TumorStudy StatusOpen
PhaseI/II
Age5 Years to 18 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDevice: Exablate Model 4000 Type 2.0/2.1 Drug: Doxorubicin
Last Posted Update2023-06-26
ClinicalTrials.gov #NCT05615623
International Sponsor
InSightec
Principal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids) - Dr. James Rutka
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

The purpose of this study is to evaluate the safety and efficacy of combining Focused Ultrasound (Exablate Model 4000 Type 2.0/2.1) with Doxorubicin therapy for the treatment of DIPG in pediatric patients.

Inclusion Criteria
  • Age between 5 and 18 years, inclusive
  • Patient diagnosed with DIPG
  • Must be between 4-12 weeks from completion of radiation therapy
  • Able to attend all study visits
  • Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
  • If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable

Additional inclusion and exclusion criteria may be discussed with you by the study team.

NANT2015-02 - Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

Closed to enrollment

NANT2015-02 - Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

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DiagnosisNeuroblastomaStudy StatusClosed to enrollment
PhaseI
AgeChild, Adult, Older Adult - (1 Year to 90 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationLorlatinib: Oral (tablet) Cyclophosphamide: IV Topotecan: IV
Last Posted Update2023-06-05
ClinicalTrials.gov #NCT03107988
International Sponsor
New Approaches to Neuroblastoma Therapy Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr.Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Some neuroblastoma have a specific genetic change or mutation called an ALK aberration.  ALK, or anaplastic lymphoma kinase, has been found in several adult and pediatric cancers.  ALK aberrations are present in about 14% of newly diagnosed patients with high-risk neuroblastoma, and can be found more frequently at the time of relapse.  Lorlatinib is a drug called an ALK inhibitor. It is expected to slow or stop the growth of cancer cells which have the ALK aberration. The aim of this phase I/II study is to evaluate the dose, safety, and tolerability of lorlatinib, including the effect it has on the cancer.  Lorlatinib will be given alone or in combination with chemotherapy in children with refractory, relapsed or progressive neuroblastoma with ALK alterations.

Inclusion Criteria
  • Patients must have a diagnosis of neuroblastoma either by histologic verification (looking at a sample of the tumour under a microscope) of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines (HVA/VMA).
  • Patients are required to have an activating ALK aberration in their tumor, which is identified through genetic testing.
  • Patients must have high risk neuroblastoma. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
  • Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease

 

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Open

PEPN2121 - A Phase 1/2 Study of Tiragolumab (NSC# 827799) and Atezolizumab (NSC# 783608) in Patients With Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

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DiagnosisRecurrent/Refractory Atypical Teratoid/Rhabdoid Tumor, Kidney Medullary Carcinoma, Malignant Solid Neoplasm, Poorly Differentiated ChordomaStudy StatusOpen
PhaseI/II
Age12 Months and olderRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: Atezolizumab (Given IV) Biological: Tiragolumab (Given IV) Procedures: CT and/or PET-CT, MRI, PET-CT and/or FDG-PET, X-Ray Imaging
Last Posted Update2023-05-29
ClinicalTrials.gov #NCT05286801
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr. Monia Marzouki
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This is a phase I/II trial that studies how well the treatments tiragolumab and atezolizumab work when given to children with tumours that have either come back (relapsed) or did not respond to therapy (refractory). These tumours must have a certain mutation, meaning the cancer cells are missing important genes called SMARCB1 and SMARCA4. Tiragolumab and atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Inclusion Criteria
  • Participants must be between 1-18 years old for part A of this study. There is no upper age limit for part B
  • Participants must have one of the following cancers, that has either come back (relapsed) or did not respond to previous treatment (refractory):
    • Renal medullary carcinoma
    • Malignant rhabdoid tumor (extra-CNS)
    • Atypical teratoid rhabdoid tumor (CNS)
    • Poorly differentiated chordoma
    • Epithelioid sarcoma
  • Cancer must have the eligible mutation (SMARCB1 or SMARCA4)
  • Participants must be up and about for at least half their waking hours
  • Participants must meet all bloodwork criteria outlined for this study

Other inclusion and exclusion criteria may apply and will be discussed with you by your clinical team

PEPN2112 - A Phase 1/ 2 Study of BAY 1895344 (Elimusertib, NSC#810486) in Pediatric Patients With Relapsed or Refractory Solid Tumors

Closed to enrollment

PEPN2112 - A Phase 1/ 2 Study of BAY 1895344 (Elimusertib, NSC#810486) in Pediatric Patients With Relapsed or Refractory Solid Tumors

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DiagnosisRecurrent/Refractory Alveolar Rhabdomyosarcoma, Ewing Sarcoma, Lymphoma, Malignant Solid Neoplasm Study StatusClosed to enrollment
PhaseI/II
Age12 Months to 30 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Elimusertib (BAY1895344, ATR inhibitor, ATR kinase inhibitor) Given PO (oral)
Last Posted Update2023-05-26
ClinicalTrials.gov #NCT05071209
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
CHU Ste Justine - Dr. Monia Marzouki
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This phase I/II trial tests the safety, best dose, and whether elimusertib works in treating patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory). Elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Inclusion Criteria
  • Age Restrictions: 
    • Part A:
      • Patients between >= 12 months and < 18 years of age
    • Part B:
      • Patients between >= 12 months and =< 30 years of age for the phase 2 expansion cohorts for both EWS and PAX3-FOXO1 ARMS.
      • Patients between >= 12 months and =< 21 years of age for the phase 2 DDR expansion cohort
  • Patients must be able to swallow tablets of the study drug (elimusertib)
  • Patients must have a solid tumor diagnosis that has come back (relapsed) or has not respond to treatment (refractory)
    • NOTE: further restrictions may apply for each cohort and will be discussed with you by the clinical team
  • Patients must have measurable disease
  • Patients must be up and about at least half of their waking hours
  • Bloodwork requirements must be met prior to treatment
  • Patients must meet the minimum duration from any prior anti-cancer therapy before enrolling. These timelines will be discussed with you by the clinical team.  
  • Patients or their substitute decision maker must sign a consent form and agree to the required study assessments

Additional inclusion and exclusion crieria may apply 

KEYNOTE-051 (MK-3475) - A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Closed to enrollment

KEYNOTE-051 (MK-3475) - A Phase I/II Study of Pembrolizumab (MK-3475) in Children With Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

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DiagnosisMelanoma, Lymphoma, Solid Tumor, Hodgkin Lymphoma, Microsatellite-instability-high Solid Tumor, Non-Hodgkin Lymphoma, Other solid tumoursStudy StatusClosed to enrollment
PhaseI/II
AgeChild - (6 Months to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT02332668
International Sponsor
Merck Sharp & Dohme Corp.
Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Catherine Vézina
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a study of pembrolizumab (antibody against a marker called PD1) in children and adolescents who have any of the following types of cancer:

  • advanced melanoma (now only open for patients age 12-18)
  • advanced, relapsed or refractory cancer (except brain tumours and leukemia) that have this PD1 marker (now closed) 
  • relapsed or refractory classical Hodgkin lymphoma 
  • advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "microsatellite-instability-high (MSI-H)"
  • advanced relapsed or refractory cancer (except brain tumours and leukemia) that is known to be "tumor-mutational burden-high" (TMB-H)"

Pembrolizumab is a human monoclonal antibody that binds and blocks PD-1 on tumors cells.  The PD-1 pathway is an immune system checkpoint that may be used by cancer tumour cells to help them trick the immune system (escape surveillance) and avoid being destroyed. By blocking the PD-1 pathway, pembrolizumab reactivates cells from the patient immune system to help it identify and destroy the cancer cells. It is expected to slow or stop the growth of cancer cells.

This study has two parts. Part 1 will find the recommended dose for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy of pembrolizumab therapy.

Inclusion Criteria
  • Age between 6 months and <18 years  (or between 3 years and <18 years of age for participants with Hodgkin's lymphoma) 
  • Locally-advanced, or metastatic cancer (except brain tumours and leukemia) that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate. The cancer type has to meet one of the following types described in the "study description" section.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
Publications

Geoerger B, Kang HJ, Yalon-Oren M, Marshall LV, Vezina C, Pappo A, Laetsch TW, Petrilli AS, Ebinger M, Toporski J, Glade-Bender J, Nicholls W, Fox E, DuBois SG, Macy ME, Cohn SL, Pathiraja K, Diede SJ, Ebbinghaus S, Pinto N. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020 Jan;21(1):121-133. doi: 10.1016/S1470-2045(19)30671-0. Epub 2019 Dec 4.

ReRAD - A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

Open

ReRAD - A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

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DiagnosisRecurrent or Progressive Diffuse Intrinsic Pontine GliomaStudy StatusOpen
PhaseII
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationPatients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG
Last Posted Update2023-01-05
ClinicalTrials.gov #NCT03126266
International Sponsor
University of Calgary
Principal Investigators for Canadian Sites
Alberta Children’s Hospital - Dr. Lucie Lafay-Cousin
Stollery Children’s Hospital - Dr. Bev Wilson
Children's Hospital of Eastern Ontario (CHEO) - Dr. Donna Johnston
Hamilton Health Sciences Centre, Mc Master University
BC Children’s Hospital – Dr. Juliette Hukin
Montreal Children's Hospital – Dr. Freeman
CHU Ste-Justine – Dr. Yvan Samson
CHU de Quebec – Dr. Samuele Renzi
Children's Hospital of Western Ontario – Dr. Shayna Zelcer
Janeway Hospital - Dr. Lynette Bowes
The Hospital for Sick Children - Dr. Ute Bartels
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive brain tumour with no effective treatment and no chance of long-term survival . When this brain tumour grows back after the initial radiation therapy, it is known as progressive or recurrent DIPG.

This study will investigate how long a second treatment with radiation (re-irradiation) keeps progressive or recurrent DIPG from growing again and the overall survival of these patients. All children enrolled will be treated with re-irradiation.

Inclusion Criteria
  • The patient is 17 years of age or younger at the time of first or second relapse or progression of disease
  • The patient has no evidence of metastases on MRI of the brain and the spine
  • The patient has received radiation in the past, given to a total dose of <60 Gy
  • At least 180 days (6 months) have elapsed from the last day of primary radiation
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team